EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)



Status:Completed
Conditions:Cardiology, Cosmetic
Therapuetic Areas:Cardiology / Vascular Diseases, Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:10/12/2018
Start Date:October 2016
End Date:June 14, 2018

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A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy

A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic
Panniculopathy (commonly known as Cellulite).


Inclusion Criteria for Observation Phase:

- Voluntarily sign and date an informed consent agreement

- Have participated in and completed the double-blind study EN3835-201

- Be willing to apply sunscreen to any treated quadrant before each exposure to sun

Inclusion Criteria for Treatment Phase:

- Voluntarily sign and date an informed consent agreement

- Have participated in and completed the double-blind study EN3835-201

- Be willing to apply sunscreen to any treated quadrant before each exposure to sun

- Have at least 1 quadrant with: a score of 3 or 4 (moderate or severe) as reported on
the PCSS (Photonumeric Cellulite Severity Scale) by the subject or investigator, and a
Hexsel CSS (Cellulite Severity Scale) score no greater than 13

- Be judged to be in good health

- Have a negative urine pregnancy test at screening and be using an effective
contraception method, be surgically sterile, or post-menopausal

Exclusion Criteria for Observation Phase:

Exclusion Criteria for Treatment Phase:

- Has used, or intends to use during the course of the study, other treatment of EFP on
the legs or buttocks

- Is presently nursing a baby or providing breast milk for a baby

- Intends to become pregnant during the study

- Currently receiving, has received within 7 days before injection of study drug, or
plans to receive an anticoagulant or antiplatelet medication

- History of stroke or bleeding
We found this trial at
14
sites
Lynchburg, Virginia 24501
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Lynchburg, VA
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Beverly Hills, California 90210
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Beverly Hills, CA
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Charlottesville, Virginia 22911
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Charlottesville, VA
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Clearwater, Florida 33756
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Clearwater, FL
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Coral Gables, Florida 33146
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Coral Gables, FL
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Murrieta, California 92562
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Murrieta, CA
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Nashville, Tennessee 37215
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Nashville, TN
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New York, New York 10003
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New York, NY
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Oceanside, California 92056
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Oceanside, CA
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Palm Beach, Florida 33401
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Palm Beach, FL
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Pflugerville, Texas 78660
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Pflugerville, TX
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San Diego, California 92121
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San Diego, CA
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Spokane, Washington 99202
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Spokane, WA
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Washington, Missouri 63090
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Washington, MO
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